SEPTEMBER 2010, Vol. 28

Goodbye “Biomedical News,” and hello “UMMS Research News!” In the interest of clarity, we’ve renamed the monthly online publication that’s your comprehensive source for updates, events, and happenings in research at the University of Michigan Medical School (UMMS).

For more information about what’s going on across the UM Medical Campus:

Health System Headlines connects you to what's happening daily throughout the Medical School, the Health System and the University.

HEADLINES

Games! Prizes! Ice Cream! Fun!

Join the UMMS Office of Research for our first-ever Researchpalooza during the annual Ice Cream Social. In addition to ice cream, popcorn, and lots of fun giveaways, the Office of Research is sponsoring prize drawings for…

Grand Prize – $2,000 for a trip to attend a research or professional development conference

PLUS great prizes from MICHR! One lucky faculty researcher will win $350 for registration at the FDA Clinical Investigator Training Course
in November in Maryland, and a staff study coordinator will win the cost of certification for either the SoCRA or ACRP exams - up to a $440 value!

Join colleagues and friends as we meet, mingle, and learn more about many of the labs and offices that offer their stellar services to faculty, students, and staff, all at one convenient time and location! Exhibiting groups with tables on Circle Drive will include…

NIH SBIR/STTR Grants and Contracts: Interested but Not Sure What, Why and How?

Wednesday, September 8, 2010
8:00 a.m. and 4:00 p.m. (The same session is offered at two different times.)
M3330 Med Sci I

The UMMS Office of Research is sponsoring a one-hour overview session that will:

Provide an overview of SBIR/STTR grants and contracts and what they fund.

Discuss the similarities and differences between SBIR/STTR grants and basic research grants, such as NIH R01 and R21.

Describe a variety of different ways that faculty members can participate in SBIR/STTR funded projects.

Explain how investigators can receive additional State-funded assistance to help pursue SBIR/STTR funding.

This session will help you decide whether to consider these NIH funding mechanisms, and also whether to attend a more intensive two-day workshop to follow on September 30 - October 1, 2010 (http://www.bbcetc.com/training.html). The overview session is presented by Lisa M. Kurek, Managing Partner, BBCetc. Contact Lisa at 734-930-9741 with any questions.

A Message from Dr. Ken Pienta on Clinical Research at UMHS: Strategic Assessment and Town Hall (September 29, 2010)

Dear Faculty and Staff,

I wanted to provide you with an update on the Strategic Assessment of the Clinical Research Enterprise (SACRE) that many of you participated in over the past year, and invite you to an interactive Town Hall on September 29, 2010 for more details.

As you may recall, SACRE was conducted from July 2009 through January 2010, involving interviews with 125 employees who are engaged in the clinical research process, and a web-based survey with 651 research faculty and staff respondents. The SACRE document, linked below, includes two sections: Phase I includes the assessment results, and Phase II presents recommendations and an implementation plan.

The assessment clearly identified eight key issues that need to be addressed, and the Michigan Institute for Clinical & Health Research (MICHR) is playing a lead role in addressing them. With the support of Dean Woolliscroft and EVPMA Ora Pescovitz, MICHR has made implementation of the SACRE recommendations an integral part of our overall FY2011 Strategic Plan.

The eight issues we are actively pursuing based on the assessment are:

Expedite the study approval/contracting process

Establish a clinical research support unit (CRSU) and "franchisable" best practices and tools

Create a home for study coordinators to promote education and sharing of best practices

Increase patient participation in clinical studies

Improve IT infrastructure

Change the clinical research culture

The full SACRE document, including the assessment results and implementation plan, is available on MICHR's website. I encourage you to review it and then attend the Town Hall where I'll provide a progress update and answer your questions.

The Medical School Office of Research is pleased to announce the release of a new position statement regarding the payment of research related injuries resulting from a clinical trial. The “UMHS Clinical Research Position Statement and Template Language” is effective as of September 1, 2010. The Office of Research has worked together with IRBMED and the Division for Research Development and Administration (DRDA) in drafting this statement. This is an important step in ensuring the financial safety of our valued research participants. It is essential that study teams understand and adopt this position as part of their interaction and negotiation with Industry sponsors. It is UMHS’s position that Industry sponsors should bear the costs for research related injuries, not only to avoid Medicare Secondary Payer (MSP) implications, but to relieve research participants of the financial burdens such as co-payments and deductibles that can be associated with clinical trial injury expenses. Federally funded projects do not provide provisions for subject injury; therefore, UMHS will pay for research related injury costs.

The Calendar Review & Analysis Office (CRAO) will continue reviewing for appropriate language in the draft Informed Consent and draft Contract. However, it is DRDA that will play a key role in negotiating contract language with Industry sponsors. DRDA will work with the study teams and sponsors to make sure the contract language reflects this position statement.

Presenter: Christine K. Black, Assistant Director of Research Services, Medical School Office of Research

This workshop is an overview of research grant proposal development. Topics include: funding opportunity databases and matching funders’ priorities; considerations in project design; and writing for relevancy, persuasion, and rave reviews. Proposals to both federal and foundation sources will be covered. During the last half-hour, a panel of successfully-funded faculty members will join us and answer questions about proposal writing.

If you have a question in advance of the workshop, you may include it on the registration form.

This workshop is sponsored by the Medical School Office of Research. Please note that if this date is inconvenient for you, a similar workshop sponsored by DRDA will be presented by Chris Black on Tuesday, November 2, 2010 (view details here).

BMRC Bridging Support Program for Biomedical Research
Deadline: Wednesday, September 15, 2010

The Medical School’s Office of Research brings your attention to a re-prioritization of the BMRC Bridging Support Program for Biomedical Research. Bridging Support provides funding for federally funded biomedical research projects with a demonstrated likelihood of continued funding after resubmission (up to $40,000 for one year from the BMRC with required matching from the PI's department). In consideration of the reduction of NIH resubmission opportunities (from two to one), the program will focus on bridging a non-funded gap of time during preparation of an A1 application, will cease to support any new grants, and will not consider previous special circumstances (e.g., first R01s following a non-renewable award, such as a K08 or R21; or R01s that spun off independently from a Program Project).

To be eligible, the PI must have submitted the renewal grant and received the reviewers' summary statement in preparation of a resubmission. Eligibility is also limited to full-time, on-campus instructional and research faculty with primary appointments in the Medical School. Grants to be bridged must reside in the Medical School.

RESEARCH COMPLIANCE TRAINING AND EDUCATION

Animal Research

Please join us for a special grand rounds presentation on the topic of “Public Opinion and the Use of Animals in Research” to be given by Paul McKellips, Executive Vice President, Foundation for Biomedical Research, Washington, DC. This presentation is hosted by the Michigan Society for Medical Research (MISMR), and the University of Michigan Medical School’s Office of Research, Office of Regulatory Affairs, and Unit for Laboratory Animal Medicine (ULAM).

eRAM Is Coming – Complete Your Amendments and Applications

With the upcoming move into eResearch Animal Management (eRAM), we would like to encourage everyone to submit and complete UCUCA amendments and renewal applications as soon as possible to prevent delays in approval. The University Committee on Use and Care of Animals (UCUCA) requests that protocols be submitted a minimum of three months prior to the expiration date to ensure that there is adequate time to prevent lapses in approval. Conducting animal activities – including housing, breeding, interventions/ experimental manipulations, and euthanasia – after a protocol has expired is a violation of National Institutes of Health (NIH) grants Policy, as well as the Public Health Service (PHS) Policy.

UCUCA – Check Us Out at Researchpalooza!

The University Committee on Use and Care of Animals (UCUCA) will be participating in the Researchpalooza on September 15, 2010 from 11:00 a.m. - 2:00 p.m. in the circle drive in front of Med Sci I. Come meet your compliance associates and the ITS eResearch Animal Management Team!

AAALAC Is on the Horizon – Help Us Achieve Excellence

The University Committee on Use and Care of Animals (UCUCA) is scheduled to have their triennial inspection by the Association for Assessment and Accreditation of Laboratory Animal Care, International in the first quarter of 2011. AAALAC's voluntary accreditation process allows research programs to demonstrate that they meet the minimum standards required by law, and are also going the extra step to achieve excellence in animal care and use. Please let us know as soon as possible if any changes need to be made to your protocol. More information regarding the site visit will be made available in the coming months.

If you ever have any questions regarding the UCUCA or anything else related to your animal work or compliance, please do not hesitate to contact the UCUCA Office (ucuca.office@umich.edu or 734-763-8028).

EDUCATIONAL OPPORTUNITIES

The second annual FDA Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration's (FDA) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI), is now open for registration.

This intensive, three-day course will enable clinical investigators to gain a greater appreciation of the scientific, ethical, and regulatory issues relating to clinical trial data that may be submitted to regulatory bodies. Attendees will have the unique opportunity of hearing directly from FDA's nationally renowned experts on issues critical to successful clinical research.

Topics to be discussed include the design, conduct, and analysis of clinical trials; regulatory considerations essential for clinical research; the role of the DSMB and IRB in clinical studies; preclinical and pharmacological issues in clinical studies; safety assessment during clinical trials; inclusion of special populations such as pregnant women in clinical studies; and the role of personalized medicine in the future of medical product development. The course has been designed with the goal of enabling investigators to improve the quality of clinical trials and to enhance the safety of trial participants.

The Graduate Student Council (GSC) cordially invites you to the Graduate Student Awards Ceremony and Ice Cream Social. The Graduate Student Awards for Excellence in (1) Research and (2) Teaching and Service will be presented. Please contact PIBS at 734-647-7005 for further information.

KUDOS

Congratulations go to Massimo Pietropaolo, M.D., Professor of Internal Medicine and Professor of Pediatrics and Communicable Diseases, who is the PI on an R01 grant titled "Enhancement of Biomarkers for Type 1 Diabetes.” The grant was funded to the tune of $3.3 million dollars to develop new studies on Type 1 diabetes at the University of Michigan in collaboration with other institutions.

“I believe that this is very important news for the Brehm Center for Diabetes Research, in its infancy,” says Dr. Pietropaolo. “I think that this achievement could give the opportunity to create new collaborations, and new grants, for the community as a whole.”

Project Summary / Abstract

The proposed research, based on our prior eight-year achievements, will investigate the role of new immunologic biomarkers in the largest population-based cohort of first degree relatives of T1DM patients with and without T1DM from the same geographical area. Growing number of pilot trials for T1DM are being conducted by international collaborative clinical research networks, such as TrialNet (http://www.diabetestrialnet.org) and the Immune Tolerance Network (http://www.immunetolerance.org) in an effort to find the cure for T1DM. There are many prevention trials in the pipeline that cannot be performed because the currently available biomarkers cannot identify a sufficient number of individuals to be enrolled in these trials. Endless discussions have taken place on how to develop new strategies to enhance sensitivity of multiple markers and in turn effectively enroll first-degree relatives in T1DM prevention trials.

Based on our most recent preliminary data, a major hypothesis of the present application is that a combination of novel biomarkers detecting antibodies directed to IA-2, GAD65 specific epitopes and the newly discovered antigen ZnT8 will further enhance sensitivity and the predictive value of T1DM progression as compared to conventional islet autoantibody markers. The proposed research will be performed at the University of Michigan using the Children’s Hospital of Pittsburgh cohort, which currently has 161 first degree relatives, who converted to insulin-requiring diabetes during follow-up (converters) from a pool of over 10,000 relatives of T1DM probands. This unique serum sample archive is ideal to test our immunologic hypotheses. This represents the largest number of converters of any center and as such, more than 200 converters should be available by the end of the next grant period. Because it is impossible to have access to pancreatic tissue and pancreatic lymph nodes from subjects at risk of developing T1DM, we feel that it is entirely appropriate to develop predictive models of pancreatic b cell destruction to understand the role of pathogenic T cell responses during the natural history of human disease. We have constructed mathematical models taking into consideration new and conventional islet autoantibody biomarkers (Specific Aim I) and high avidity T cells which leads to b cell destruction during T1DM progression (Specific Aim II). We have coupled laboratory-based methodology with mathematical modeling of T1DM progression and have assembled an unprecedented team of leading experts in immunology research and mathematical predictive models of b cell destruction. Modeling key elements of T1DM progression (islet autoantibodies, T cell avidity, ER stress and UPR interactions) fits well with the experimental design and may ultimately validate a subset of T cells and/or the UPR pathway as drug targets and prove useful in guiding drug discovery to treat T1DM. The outcome of the proposed investigation should allow for the development of new biomarkers, modeling of key elements associated with T1DM progression and facilitate major clinical trials aimed at evaluating new approaches for understanding, preventing and treating Type 1 diabetes.

Project Narrative

The use of molecular immunology-based research can be applied to reliably identify the earliest signs of islet autoantibodies which indicates that the autoimmune process leading to pancreatic beta cell injury has already initiated. It is likely that the appearance of these white cells contribute to the destructive process of pancreatic beta cells, a prelude of clinically overt Type 1 diabetes mellitus. Our research has major public health implications and together with modeling of key elements of Type 1 diabetes progression these studies will also provide a conceptual framework for designing new algorithms used for enrolling new subjects at risk in major clinical trials aimed at preventing Type 1 diabetes.

FUNDING / AWARD OPPORTUNITIES

Abstracts listed here are general information about these funding programs. We strongly urge interested applicants to visit the listed website to verify complete eligibility, program information, and application procedures before submitting an application.

(Grants may not be reviewed in a given month if too few are received. Grants are not reviewed in July and August.)

The UM Comprehensive Cancer Center's Cancer Research Committee invites applications from faculty requesting support for investigator-initiated research proposals that focus on the cancer problem or that have clear cancer relevance. For further information, visit (http://sitemaker.umich.edu/cccresearchgrants/home).

Research Grants are available for an investigator for cancer-related research, or for any interesting and innovative collaboration between scientists. The fund is available for faculty in any unit of the University. The total amount requested must not exceed $40,000.

Idea Grants are available for an investigator who has a novel and innovative idea for cancer research. Preliminary data to support the feasibility of the proposed studies are not required. However, preliminary data may be helpful in assessing the merits of the application and applicants are encouraged to include preliminary data if they are available. Funding will not exceed $30,000.

External Limited Submissions

These are opportunities in which the sponsor has limited the number of proposals allowed from an institution. These competitions require an internal review to select the proposals to submit to the sponsor from the University of Michigan.

The Harold M. Weintraub Graduate Student Award recognizes outstanding achievement during graduate studies in the biological sciences. Awardees will participate in a scientific symposium honoring Hal Weintraub and his commitment to innovative science. The award symposium will consist of scientific presentations by the graduate student awardees and informal gatherings of students and faculty. The graduate student awardees are expected to be advanced students near the completion of their studies. Nominated students should not have graduated before September 2010. The Fred Hutchinson Weintraub and Groudine Fund, established to foster intellectual exchange through the promotion of programs for graduate students, fellows and visiting scholars, will cover expenses for the graduate student awardees. Only one nomination may be submitted per department or program. Visit the website for complete information.

Center for Organogenesis - Research Team Program - New Pilot Funding
Deadline: September 15, 2010 (Letter of Intent)website

The Greenwall Foundation Faculty Scholars Program in Bioethics
Internal Deadline: October 1, 2010
Foundation Deadline: November 1, 2010 (Preliminary Application)website
Direct any questions to Jane Ritter at (ritterj@umich.edu) or 734-763-1290.

Grants for Early Medical/Surgical Subspecialists’ Transition to Aging Research (R03)
Deadline: October 3, 2010 (Letter of Intent)website
Jeffrey Halter, Director of the Geriatrics Center and Institute of Gerontology at UM, can answer questions about this program, facilitate applications, etc. He can be reached at (jhalter@umich.edu).

PI: *Engel,JamesTitle: 5th International Conference on GATA Factors: GATA Factors in Development and DiseaseSponsor: The Company Biologists LimitedProject Dates and Amount of Award: 08/01/10-07/31/11; $4,580

PI: *Peters-Golden,MarcTitle: Role of Leukotrienes in Mediating MyD88-Induced NFkappaB Activation: from the Plasma Membrane to the Nucleus.Sponsor: American Heart Assoc, Inc.Project Dates and Amount of Award: 07/01/10-06/30/14; $308,000

PI: *Swanson,JoelTitle: SOFTWARE AND INSTRUMENTATION FOR 3D-IMAGING OF MULTIPLE MOLECULAR INTERACTIONS IN LIVING CELLSSponsor: National Science Foundation-Subcontracts TO South Dakota State UniversityProject Dates and Amount of Award: 08/01/10-07/31/12; $15,000

PI: *Pletcher,ScottTitle: Modulation of Lifespan by the Transsulfuration PathwaySponsor: Ellison Medical Foundation TO American Federation for Aging ResearchProject Dates and Amount of Award: 07/01/10-06/30/11; $50,210

PI: *Zacks,DavidTitle: Effect of Chemokine Interleukin-8 and its Receptor CXCR2 on Glial Cell Activation in the Retina in an Animal Model of Choroidal NeovascularizationSponsor: Midwest Eye Banks and Transplantation CenterProject Dates and Amount of Award: 07/01/10-06/30/11; $2,500

PI: *Chinnaiyan,ArulTitle: THE ROLE OF MICRORNA MIR-101 IN PROSTATE CANCER PROGRESSIONSponsor: US DOD-Army, Department of theProject Dates and Amount of Award: 09/01/10-09/30/12; $123,921

PI: *Chinnaiyan,ArulCo-I: Prensner, John (Ctr fr Translational Pathology)Title: THE ROLE OF SOX4 IN PROSTATE CANCER METASTASESSponsor: US DOD-Army, Department of theProject Dates and Amount of Award: 09/01/10-09/30/12; $98,091

PI: *Hurvitz,EdwardCo-I: Ashton-Miller, James (Mechanical Engineering) / Eckner, James () / Richardson, James (Physical Medicine & Rehab Dept)Title: THE ROLE OF BECK STRENGTH AND REACTION TIME ON PROTECTIVE HEAD MANEUVERS AND BRACING: EFFECT OF AGE AND GENDERSponsor: NIH TO University of Pittsburgh K12Project Dates and Amount of Award: 07/01/10-08/31/10; $116,100

PI: *Nemzek,JeanTitle: Immunological Impact of Buprenorphine Analgesia on a Model of Sepsis: Influences of Strain, Sex and Disease SeveritySponsor: American College of Laboratory Animal Medicine Foundation (ACLAM)Project Dates and Amount of Award: 07/01/10-06/30/11; $30,000

Booher Anna M, Bach David S. Acquired pulmonary vein stenosis: one problem, two mechanisms. Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography. 2010 Aug. 23(8): 904.e1-3. PMID# 20138470